Protect consumers from illness

UPDATED: FDA promises faster, aggressive food safety enforcement


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Published on 08/06/2009 11:38am By Bob Luder


(UPDATED 4:15 p.m. Aug. 6) The Food and Drug Administration will enforce food safety standards faster, crack down on violators and work with state and local health departments when investigating foodborne illness outbreaks.

FDA commissioner Margaret Hamburg announced the agency’s new emphasis on swift, aggressive and effective enforcement of laws and regulations on Aug. 6.

Hamburg said in a news release that some enforcement actions in the past had been “hampered by unreasonable delays” and had taken too long to be addressed.

“The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible,” Hamburg told a group of industry representatives, attorneys, consumers and others attending a speech sponsored by the Food and Drug Law Institute in Washington D.C. “We must get the word out that the FDA is on the job.”

Hamburg said procedures for enforcement actions by the agency “can be too long and arduous when the public’s health is in jeopardy.”

Hamburg highlighted six steps the agency is taking immediately to improve the effectiveness and timeliness of the enforcement system:

  • Set shorter deadlines, generally giving no more than 15 days for offenders to respond to inspection findings;
  • Take steps to speed the warning letter process;
  • Work closer with other agencies — for instance, state, local and international officials, who can act more quickly than FDA when public health is at risk;
  • Prioritize follow-up on enforcement actions;
  • Be prepared to take immediate action in response to public health risks; and
  • Implement a formal warning letter close-out process, providing motivation for corrective action by issuing a notice on the FDA’s Web site when such actions are completed.

Hamburg said these steps would ensure that “inspection results are taken seriously, that warning letters and enforcement actions occur in a timely manner and that steps are taken to protect consumers in cases where immediate enforcement action is not possible.”

Tom Stenzel, president and chief executive officer of the United Fresh Produce Association, said it is important that state and local governments play key roles in food safety issues, as long as its coordinated under the FDA’s authority.

“I think it’s good,” Stenzel said. “For too long, the FDA has been complaining people aren’t doing the right things, but take no action. The flipside is, don’t get it wrong if you’re the FDA.

“We support strong action as long as they have the right player.”


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